Phase II Evaluation of AHCC for the Eradication of HPV Infections (AHCC4HPV)
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|ClinicalTrials.gov Identifier: NCT02405533|
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : January 20, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus Dysplasia CIN1 CIN2||Dietary Supplement: AHCC 3 grams once a day Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Randomized, Double-blind, Placebo-controlled Evaluation of AHCC (Active Hexose Correlated Compound) for the Eradication of HPV Infections in Women With HPV Positive Pap Smears|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
Experimental: Group 1
AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
Dietary Supplement: AHCC 3 grams once a day
AHCC supplementation x 6 months with Placebo x 6 months
Other Name: active hexose correlated compound
Placebo Comparator: Group 2
Placebo once a day on an empty stomach x 12 months
Placebo supplementation x 12 months
- Roche, COBAS HPV DNA Assay (Pleasanton, CA) [ Time Frame: once every 3 months for 12 months up to 18 months ]HPV DNA testing
- Interferon beta [ Time Frame: once every 3 months for 12 months up to 18 months ]Evaluation of Interferon Beta level
- Interferon gamma [ Time Frame: once every 3 months for 12 months up to 18 months ]Evaluation of Interferon gamma level
- NK Cells [ Time Frame: once every 3 months for 12 months up to 18 months ]Evaluation of Natural Killer (NK) cells
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|Ages Eligible for Study:||30 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
• Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.
Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia
- 1 greater than 6 months and no more than 18 months prior to study entry
- 1 greater than 24 months prior to study entry.
- Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
- Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC >/= 1,500 cells/mm3, platelets 100,000 >/= cells/mm3; Creatinine clearance>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase </= 1.5 times normal.
- Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.
• History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90).
- Women with a current or prior diagnosis of cancer
- Women with a current diagnosis of CIN3 cervical dysplasia
- Women that are pregnant or breast feeding.
- Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive
- Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures.
- Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants)
- Women that have taken AHCC within the past six months.
- Women currently taking other immune modulating nutritional supplements.
- Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405533
|United States, Texas|
|UTHealth Medical School at Houston|
|Houston, Texas, United States, 77030|
|Study Chair:||Judith A Smith, Pharm.D.||UTTexas_Houston|
|Responsible Party:||Judith A. Smith, Associate Professor & Director of WHIM Research Program, The University of Texas Health Science Center, Houston|
|Other Study ID Numbers:||
|First Posted:||April 1, 2015 Key Record Dates|
|Last Update Posted:||January 20, 2021|
|Last Verified:||January 2021|
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
DNA Virus Infections
Tumor Virus Infections